The Recall Desk
HighFDA (Devices)·Z-2490-2018·Announced 2018-07-25

Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (continuous suction) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Cardinal Health 200, LLC is recalling specific lots of Hydroline Trumpet Valves (Ref ASU1200). The recall involves 63,020 valves distributed to 34 U.S. states, the District of Columbia, government and military facilities, and several foreign countries including Belgium, France, Germany, Israel, Italy, the Netherlands, Singapore, and the United Kingdom.

The recall was initiated because the suction valve may not close properly, which could cause continuous suction. The affected product is a sterile, single-use, prescription medical device. Specific lot numbers involved in the recall include 21706, 21707, 31751, 31748, 31750, 31753, 41719, 41720, 61717, 61718, 61719, 71736, 71737, 91702, 91705, 91706, and 91721.

Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the affected valves. Users should contact Cardinal Health 200, LLC for further instructions on how to return or dispose of the product.

The recalled product

Product
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical / Anesthesia
Hazard
Affected units
63,020

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Lot numbers 21706
  • 21707
  • 31751
  • 31748
  • 31750
  • 31753
  • 41719
  • 41720
  • 61717
  • 61718
  • 61719
  • 71736
  • 71737
  • 91702
  • 91705
  • 91706
  • and 91721.

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 11 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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